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HMA eSubmission Roadmap

TIGes Harmonised eCTD Guidance

TIGes Harmonised NeeS Guidance

EMA eSubmission Guidance for the Centralised Procedure

  • All EMA guidance documents, both practical and strategic, as well as Statements of Intent relating to eCTD and electronic submissions, can be found on the EMA external website here

Best Archiving Practice

 

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